NCT00734344 is a NA clinical trial of Raltegravir in Acute HIV Infection, sponsored by University of Alabama at Birmingham.

Who is sponsoring NCT00734344?

NCT00734344 is sponsored by University of Alabama at Birmingham.

What drugs are being tested in NCT00734344?

Interventions in NCT00734344: Raltegravir, Efavirenz, Emtricitibine, Tenofovir disoproxil once daily, Tenofovir disoproxil twice daily.

What condition does NCT00734344 study?

NCT00734344 studies Acute HIV Infection.

Is NCT00734344 still recruiting?

NCT00734344 is currently completed. Last updated 25 April 2016.

Are results published for NCT00734344?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-04-25 · How we verify

NCT00734344

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis

Completed NA Results posted Last updated 25 April 2016

What this trial tests

NA trial testing Raltegravir in Acute HIV Infection in 18 participants. Completed in 1 September 2012.

Timeline

1 September 2008

Primary endpoint
1 August 2012

1 September 2012

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	1 September 2008
Primary completion	1 August 2012
Estimated completion	1 September 2012
Sites	1 location across United States

Drugs / interventions tested

Raltegravir — full drug profile →
Efavirenz (EFAVIRENZ) — full drug profile →
Emtricitibine — full drug profile →
Tenofovir disoproxil once daily — full drug profile →
Tenofovir disoproxil twice daily — full drug profile →

Conditions studied

Acute HIV Infection — all drugs for Acute HIV Infection →

Sponsor

University of Alabama at Birmingham

Who can join

19 and older, any sex, with Acute HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean White Blood Cell Count Between Treatment Groups at 2 Months
Time frame: baseline to 2 months
Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 4 Months
Time frame: 4 months post baseline
Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 6 Months
Time frame: 6 months after baseline
Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 8 Months
Time frame: 8 months after baseline
Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 10 Months
Time frame: 10 months after baseline
Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 12 Months
Time frame: 12 months after baseline
Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).

Sponsor's own description

This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Raltegravir

Trials testing the same drug.

NCT05751031 — Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnan · unknown
NCT03954327 — Combination Antiretroviral Therapy (cART) for PBC · Phase 2 · completed
NCT03667547 — Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851) · Phase 4 · completed
NCT03333083 — Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 · Phase 3 · terminated
NCT03311945 — Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg · Phase 3 · completed

Other recruiting trials for Acute HIV Infection

Currently open trials in the same condition.

NCT06484335 — RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV · Phase 1 · recruiting
NCT05719441 — A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation Dur · Phase 2 · recruiting
NCT05728996 — Netherlands Cohort Study on Acute HIV Infection · recruiting

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00734344 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 25 April 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00734344.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing